SALT LAKE CITY , March 12, 2025 /PRNewswire/ -- Lipocine Inc. (NASDAQ: LPCN ), a biopharmaceutical company leveraging its proprietary technology platform to augment therapeutics through effective oral delivery, today announced that the U.S.
Food and Drug Administration (FDA) has recently informed sponsors of approved testosterone products about class-wide labeling changes. This decision follows the Agency's review of the findings from the Testosterone Replacement Therapy for Assessment of Long-term Vascular Events and Efficacy Response in Hypogonadal Men (TRAVERSE) clinical trial and the results from required post market ambulatory blood pressure (ABPM) studies. Based on the TRAVERSE trial results, the FDA has recommended that the Boxed Warning related to an increased risk of adverse cardiovascular outcomes be removed from the labels of testosterone products.
Additional recommendations include adding the results of the TRAVERSE trial to all testosterone products and retaining "Limitation of Use" language for age-related hypogonadism. The FDA is also requiring all labels to include product-specific information on increased blood pressure for testosterone products based on the results of ABPM studies. "We are excited about these label changes, including the removal of the Boxed Warning, as we expect the changes to be beneficial to our approved testosterone replacement therapy product as well as for our obesity management and liver disease development candidates," said Dr.
Mahes.
